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NCT01215864 · ClinicalTrials.gov registry record · Phase 1

Study of Intravenous TCD-717 in Patients With Advanced Solid Tumors

A Phase 1 study of Advanced Solid Tumors, sponsored by Traslational Cancer Drugs Pharma, SL.

Completed
Registry status
Phase 1
Development phase
28
Enrollment target
2
Study locations

NCT01215864 is a Phase 1 study of Advanced Solid Tumors that has completed, run by Traslational Cancer Drugs Pharma, SL. The registered enrollment target is 28 participants, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (86% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT01215864, a Phase 1 study of Advanced Solid Tumors, has completed, sponsored by Traslational Cancer Drugs Pharma, SL.

COMPLETED
Registry status
Phase 1
Development phase
28 participants
Enrollment target
2
Study locations

Study Summary

This is a Phase I dose escalation study of TCD-717, a novel drug that is a specific inhibitor of the enzyme choline kinase alpha, in patients with advanced solid tumors. The objectives of this study are to evaluate the safety of the drug and to determine the maximum tolerated dose and appropriate dose for phase II studies. Secondary objectives are to measure the efficacy of TCD-717; and in a substudy to be conducted in the MTD confirmation cohort only, to evaluate the potential correlation between the levels of tumor choline and tumor response to the choline kinase alpha inhibitor, TCD-717, using magnetic resonance spectroscopy. Pharmacokinetics analysis will be performed on patients enrolled in the maximum tolerated dose confirmation cohort.

Conditions Studied

Advanced Solid Tumors

Interventions

  • DRUG TCD-717

Study Locations (2)

Maryland

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore

Michigan

  • Barbara Ann Karmanos Cancer Institute - Detroit

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2011-01
Est. Completion 2014-02
Phase Phase 1

Sponsor

Traslational Cancer Drugs Pharma, SL

1 total trials

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What the Registry Record Tells You About NCT01215864

The ClinicalTrials.gov registry entry for NCT01215864 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (86% lower). The listed sponsor is Traslational Cancer Drugs Pharma, SL, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which TCD-717 is the first listed.

NCT01215864 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Maryland, Michigan.

Frequently Asked Questions

What is clinical trial NCT01215864 about?

NCT01215864 is a clinical study titled "Study of Intravenous TCD-717 in Patients With Advanced Solid Tumors". This is a Phase I dose escalation study of TCD-717, a novel drug that is a specific inhibitor of the enzyme choline kinase alpha, in patients with advanced solid tumors. The objectives of this study are to evaluate the safety of the drug and to determine the maximum tolerated dose and appropriate do...

What is the current status of trial NCT01215864?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2011-01. Estimated completion is 2014-02.

What conditions does trial NCT01215864 study?

This clinical trial studies the following conditions: Advanced Solid Tumors.

What interventions are being tested in trial NCT01215864?

The interventions under investigation include: TCD-717 (DRUG).

Who is sponsoring clinical trial NCT01215864?

This trial is sponsored by Traslational Cancer Drugs Pharma, SL, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01215864 being conducted?

This trial has 2 study locations across Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.